Accelerated Recovery After MIS Hepatectomy (ARAMIS Hep) to Support Early Discharge for Patients Undergoing Minimally Invasive Liver Resection
Study Details
Study Description
Brief Summary
To learn if an accelerated recovery program can shorten the length of hospital stay in patients having minimally invasive liver surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Primary Objectives:
Our study will investigate the feasibility of an accelerated recovery program to minimize length of stay (LOS) and facilitate outpatient surgery for patients undergoing minimally invasive, lower complexity (Kawaguchi-Gayet grade I) liver resection. This program (ARAMIS Hep) will combine minimally invasive surgical (MIS) approaches (robotic OR laparoscopic), enhanced recovery after surgery (ERAS) protocols, and Telehealth to liberalize discharge criteria in a safe manner.
Secondary Objectives:
In addition to demonstrating a reduction in LOS, our study will also provide preliminary data to aid in the broader implementation of this approach. Specifically, we will gain insight into the patient experience, measure patient-reported outcomes on recovery trajectories, and understand barriers to integrating a novel pathway into existing institutional frameworks.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Accelerated Recovery Protocol Participants will be assigned to either the accelerated recovery program with minimal length of stay or the routine follow-up schedule/length of stay. Participants will fill out up to 14 questionnaires, over a 30-day period, asking about how you feel. You will complete a telehealth visit after surgery (for those assigned to the accelerated recovery program). Participants will have in-person visits within 2 weeks of surgery and 90 days after surgery. |
Behavioral: Questionnaires
Survey
|
| Experimental: Comparison/Control Arm standard post-operative care |
Behavioral: Questionnaires
Survey
|
Outcome Measures
Primary Outcome Measures
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [through study completion; an average of 1 year.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Tumor amenable to MIS Kawaguchi-Gayet grade I hepatectomy (see figure 1 below)
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No evidence of cirrhosis (based on imaging, evidence of portal hypertension, clinical features, or laboratory results)
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No significant cardiopulmonary disease that would prevent patients from undergoing MIS resection
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Ability to stay within 50 miles of medical center for immediate postop period
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Age of 18 years or above - because no adverse event data are currently available on enhanced recovery and early discharge after hepatic resection for patients <18 years of age, children are excluded from this study
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Ability to understand and the willingness to sign a written informed consent document
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Non-English-speaking patients are eligible for participation
Exclusion Criteria:
Patients who will be excluded include those with:
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Tumors NOT amenable to MIS Kawaguchi-Gayet grade I hepatectomy
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Tumors not amenable to MIS or Robotic-assisted surgical resection
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Evidence of Cirrhosis on imaging, clinically, or lab testing
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Inability to stay within 50 miles of the Cancer Center in the immediate post-operative period
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Age below 18 years
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Inability to consent for trial/protocol
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Patients who are pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- Intuitive Surgical Inc
Investigators
- Principal Investigator: Hop Tran Cao, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2022-0917
- NCI-2023-04169